Outcome Study of Endoscopically Inserted Gastrostomy (PEG)Versus Radiologically-guided Insertion of Gastrostomy (RIG)in Children (PEG Vs RIG)

NHS Foundation Trust

Status: Unknown

Conditions: Two Interventions (PEG and RIG) Compared Against Each Other

Treatments: Procedure: Percutaneous Endoscopic Gastrostomy; Procedure: Radiologically-guided insertion of Gastrostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01920438

10SG14

Details and patient eligibility

About

A gastrostomy is a feeding tube that communicates from the skin directly into the stomach. It is a device frequently used in children that have feeding difficulties or are unable to maintain normal growth via oral feeds. The same device may be inserted in two ways: the percutaneous endoscopic method (PEG) which is guided by the use of an endoscope (flexible camera), or the radiologically inserted method (RIG) which is guided by the use of X-ray imaging. Both methods of insertion have been used in children for more than 20 years, but it is not clear which is the best method. Both methods are associated with complications, including injury to other abdominal organs and leakage leading to sepsis. There are no randomised controlled trials comparing the two techniques.

We aim to compare the outcome of both methods of gastrostomy insertion in children, with emphasis on the complication rates. We have devised a complication score with weightage assigned to each complication according to its severity.

A randomised controlled trial will be performed in children requiring a gastrostomy, 100 per group. The primary outcome will be the overall total complication rate.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• any child referred for gastrostomy insertion

Exclusion criteria

• the child has gastro-esophageal reflux and is being considered for anti-reflux surgery
• previous gastrostomy or fundoplication
• previous extensive abdominal surgery
• the child requires a concomitant major procedure on the gut or other intra- abdominal organs

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

PEG

Experimental group

Description:

Percutaneous Endoscopic Gastrostomy

Treatment:

Procedure: Percutaneous Endoscopic Gastrostomy

RIG

Experimental group

Description:

Radiologically-guided Insertion of Gastrostomy

Treatment:

Procedure: Radiologically-guided insertion of Gastrostomy